UNITED STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form 6-K
REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16
UNDER THE SECURITIES EXCHANGE ACT OF 1934
For the
month of June, 2019
Commission
File Number 001-15170
GlaxoSmithKline plc
(Translation
of registrant's name into English)
980 Great West Road, Brentford, Middlesex, TW8
9GS
(Address
of principal executive office)
Indicate
by check mark whether the registrant files or will file annual
reports under cover of Form 20-F or Form 40-F.
Form
20-F . . . .X. . . . Form 40-F . . . . . . . .
Indicate
by check mark if the registrant is submitting the Form 6-K in paper
as permitted by Regulation S-T Rule 101(b)(1): ____
Indicate
by check mark if the registrant is submitting the Form 6-K in paper
as permitted by Regulation S-T Rule 101(b)(7): ____
Issued: Thursday 6 June 2019, London UK - LSE
announcement
Nucala (mepolizumab) gains FDA approval for two new
self-administration options
First anti-IL5 biologic to give healthcare professionals choice of
how and where their patients receive treatment
GlaxoSmithKline (LSE/NYSE: GSK) today announced that
the US Food and Drug Administration (FDA) has approved two new
methods for administering Nucala (mepolizumab), an autoinjector and
a pre-filled safety syringe, for patients or caregivers to
administer once every four weeks, after a healthcare professional
decides it is appropriate. This is the first anti-IL5 biologic to
be licensed in the US for at-home administration, and the first
respiratory biologic to be approved for administration via an
autoinjector.
This approval will give healthcare professionals and people living
with severe eosinophilic asthma (SEA) or the rare
disease eosinophilic granulomatosis with
polyangiitis (EGPA) the option for Nucala to be administered
outside of a clinical setting by a patient or caregiver
after their healthcare professional agrees this approach is
appropriate. The original lyophilised powder version remains
available for administration by a healthcare
professional.
Dr Hal Barron, Chief Scientific Officer and President, R&D,
GSK, said: "Nucala's efficacy is well-established and this approval
means that, for the first time, we are able to provide patients
living with these debilitating conditions the option of receiving
this important medicine in their own home".
Tonya Winders, President, Global Allergy and Asthma Patient
Platform (GAAPP), added: "People living with conditions like
severe asthma often struggle to control their day-to-day symptoms,
making routine activities like attending healthcare appointments a
challenge. Empowering patients to take their medicines at home is
an approach that has been successful in other chronic diseases such
as diabetes and rheumatoid arthritis. GAAPP welcomes this approval
for Nucala so it can be administered in a doctor's office or in the
convenience of a patient's home."
The approval is supported by
positive
patient experience data from two open-label, single-arm, phase IIIa
studies (NCT03099096 & NCT03021304) evaluating the real-world
use of Nucala administered via the new options in-clinic and at
home by patients with SEA, or by their caregivers. Both studies
showed patients were able to successfully self-administer treatment
with both the autoinjector and pre-filled syringe after appropriate
training (89-95% and 100% respectively). In addition, the majority
of patients preferred at home self-administration options compared
to in-clinic administration.
A further open-label, parallel-group, single-dose study
(NCT03014674) confirmed that the pharmacokinetic and
pharmacodynamic profile of Nucala administered via pre-filled
syringe or autoinjector was comparable to the originally approved
lyophilised formulation.
Following this approval, it is expected that the new administration
options for Nucala will be available in the US
shortly.
About severe asthma and eosinophilic inflammation
Severe asthma is defined as asthma which requires treatment with
high dose inhaled corticosteroids (ICS) plus a second controller
(and/or systemic corticosteroids) to prevent it from becoming
'uncontrolled' or which remains 'uncontrolled' despite this
therapy. Severe asthma patients are also often categorised by
long-term use of oral corticosteroids (OCS). In a sub-set of severe
asthma patients, the over-production of eosinophils (a type of
white blood cell) is known to cause inflammation in the lungs.
Interleukin-5 (IL-5) is the main promoter of eosinophil growth,
activation and survival and provides an essential signal for the
movement of eosinophils from the bone marrow into the lung. Studies
suggest that approximately 60% of patients with severe asthma have
eosinophilic airway inflammation.
About eosinophilic granulomatosis with polyangiitis
(EGPA)
Eosinophilic granulomatosis with polyangiitis, formerly known as
Churg-Strauss Syndrome, is a chronic rare disease that is caused by
inflammation in the walls of small-to-medium sized blood vessels
(vasculitis). Approximately five people out of every one million
will be diagnosed with EGPA each year worldwide, with an estimated
prevalence of approximately 14-45 per million. The mean age of
diagnosis is 48 years, and the disease can be life-threatening for
some patients. In EGPA, patients usually develop asthma initially,
before the vasculitis extends to inflammation in the walls of small
blood vessels that supply tissues in the lungs, sinuses, skin,
nerves and other organs. EGPA can result in damage to multiple
organs in the body.
About Nucala (mepolizumab)
First approved in 2015 for severe eosinophilic asthma, mepolizumab
is the first-in-class monoclonal antibody that targets IL-5. It is
believed to work by preventing IL-5 from binding to its receptor on
the surface of eosinophils. Inhibiting IL-5 binding in this way
reduces blood eosinophils.
Mepolizumab has been developed for the treatment of diseases that
are driven by inflammation caused by eosinophils. It has been
studied in over 3,000 patients in 21 clinical trials across a
number of eosinophilic indications and has been approved (under the
brand name Nucala) in the US, Europe and in over 20 other markets,
as an add-on maintenance treatment for patients with severe
eosinophilic asthma. It is also the only anti-IL5 biologic therapy
approved for paediatric use from aged six to 17 in Europe in severe
eosinophilic asthma. In the US, Japan and Canada and a number of
other markets, it is approved as add-on maintenance treatment for
patients with EGPA. Mepolizumab is currently being investigated for
severe hypereosinophilic syndrome, nasal polyposis and
COPD.
In the US, Nucala (100mg fixed dose subcutaneous injection of
mepolizumab) is licensed as an add-on maintenance
treatment for patients with severe asthma aged 12 years and older,
and with an eosinophilic phenotype. Nucala (3x 100mg subcutaneous
injection of mepolizumab) is licensed for the treatment of adult
patients with eosinophilic granulomatosis with polyangiitis (EGPA).
Nucala is not approved for the relief of acute bronchospasm or
status asthmaticus. Full US Prescribing Information is
available at
US Prescribing
Information Nucala.
Nucala injection is intended for use under the guidance of a
healthcare provider. A patient may self-inject or the patient
caregiver may administer Nucala injection subcutaneously after the
healthcare provider determines it is appropriate. The healthcare
provider should provide proper training in subcutaneous injection
technique and on the preparation and administration of Nucala
injection prior to use according to the "Instructions for
Use".
Important safety information for Nucala (mepolizumab)
The following information is based on the US Prescribing
Information for Nucala. Please consult the full Prescribing
Information for all the labelled safety information for
Nucala.
CONTRAINDICATIONS
Nucala should not be administered to patients with a history of
hypersensitivity to mepolizumab or excipients in the
formulation.
WARNINGS AND PRECAUTIONS
Hypersensitivity Reactions
Hypersensitivity reactions (e.g. anaphylaxis, angioedema,
bronchospasm, hypotension, urticaria, rash) have occurred following
administration of Nucala. These reactions generally occur within
hours of administration but in some instances can have a delayed
onset (i.e. days). In the event of a hypersensitivity reaction,
Nucala should be discontinued.
Acute Asthma Symptoms or Deteriorating
Disease
Nucala should not be used to treat acute asthma symptoms, acute
exacerbations, or acute bronchospasm.
Opportunistic Infections: Herpes Zoster
In controlled clinical trials, 2 serious adverse reactions of
herpes zoster occurred in subjects treated with Nucala compared to
none in placebo. Consider varicella vaccination if medically
appropriate prior to starting therapy with Nucala.
Reduction of Corticosteroid Dosage
Do not discontinue systemic or inhaled corticosteroids (ICS)
abruptly upon initiation of therapy with Nucala. Decreases in
corticosteroid doses, if appropriate, should be gradual and under
the direct supervision of a physician.
Reduction in corticosteroid dose may be associated
with systemic withdrawal symptoms and/or unmask conditions
previously suppressed by systemic corticosteroid
therapy.
Parasitic (Helminth) Infection
It is unknown if Nucala will influence a patient's
response against parasites. Treat patients with pre-existing
helminth infections before initiating therapy with Nucala. If
patients become infected while receiving treatment
with Nucala and do not respond to anti-helminth
treatment, discontinue treatment with Nucala until
infection resolves.
ADVERSE REACTIONS
The most common adverse reactions (≥3% and more common than
placebo) reported in the first 24 weeks of two clinical trials
with Nucala (and placebo) were: headache, 19% (18%);
injection site reaction, 8% (3%); back pain, 5% (4%); fatigue, 5%
(4%); influenza, 3% (2%); urinary tract infection 3% (2%);
abdominal pain upper, 3% (2%); pruritus, 3% (2%); eczema, 3%
(<1%); and muscle spasm, 3% (<1%).
Systemic Reactions, including Hypersensitivity Reactions: In
3 clinical trials, 3% of subjects who
received Nucala experienced systemic (allergic and
nonallergic) reactions compared to 5% in the placebo group.
Systemic allergic/hypersensitivity reactions were reported by 1% of
subjects who received Nucala compared to 2% of subjects
in the placebo group. Manifestations included rash, pruritus,
headache, and myalgia. Systemic nonallergic reactions were reported
by 2% of subjects who received Nucala and 3% of subjects
in the placebo group. Manifestations included rash, flushing, and
myalgia. A majority of the systemic reactions were experienced on
the day of dosing. Reports of anaphylaxis have been received
postmarketing.
Injection site reactions (e.g. pain, erythema, swelling, itching,
burning sensation) occurred at a rate of 8% in subjects treated
with Nucala compared with 3% in subjects treated with
placebo.
USE IN SPECIFIC POPULATIONS
The data on pregnancy exposures from the clinical trials are
insufficient to inform on drug-associated risk. Monoclonal
antibodies, such as mepolizumab, are progressively transported
across the placenta in a linear fashion as pregnancy progresses;
therefore, potential effects on a foetus are likely to be greater
during the second and third trimesters of pregnancy.
GSK's commitment to respiratory disease
For 50 years, GSK has led the way in developing medicines that
advance the management of asthma and COPD. From introducing the
world's first selective short-acting beta agonist in 1969, to
launching six treatments in five years to create today's
industry-leading respiratory portfolio, we continue to innovate so
we can reach the right patients, with the right treatment. Working
together with the healthcare community, we apply world-class
science to discover and understand the molecules that become the
medicines of tomorrow. We won't stand still until the simple act of
breathing is made easier for everyone.
GSK
- a science-led global
healthcare company with a special purpose: to help people do more,
feel better, live longer. For further information please
visit
www.gsk
.com
Trademarks are owned by or licensed to the GSK group of
companies.
GSK enquiries:
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UK
Media enquiries:
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Simon
Steel
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+44 (0)
20 8047 5502
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(London)
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Tim
Foley
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+44 (0)
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(London)
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US
Media enquiries:
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Evan
Berland
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751 5497
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(Philadelphia)
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Analyst/Investor
enquiries:
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Sarah
Elton-Farr
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+44 (0)
20 8047 5194
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(London)
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James
Dodwell
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+44 (0)
20 8047 2406
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(London)
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Danielle
Smith
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+44 (0)
20 8047 7562
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(London)
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Jeff
McLaughlin
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+1 215
751 7002
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(Philadelphia)
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Cautionary statement regarding forward-looking
statements
GSK cautions investors that any forward-looking statements or
projections made by GSK, including those made in this announcement,
are subject to risks and uncertainties that may cause actual
results to differ materially from those projected. Such factors
include, but are not limited to, those described under Item 3.D
Principal risks and uncertainties in the company's Annual Report on
Form 20-F for 2018.
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Registered in England & Wales:
No. 3888792
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Registered Office:
980 Great West Road
Brentford, Middlesex
TW8 9GS
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SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the
registrant has duly caused this report to be signed on its behalf
by the undersigned, thereunto duly authorised.
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GlaxoSmithKline plc
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(Registrant)
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Date: June
7, 2019
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By:/s/ VICTORIA
WHYTE
--------------------------
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Victoria Whyte
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Authorised
Signatory for and on
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behalf
of GlaxoSmithKline plc
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